Regulatoy Affairs

Descripción del empleo

About Théa

Laboratorios Théa is part of the independent Théa Group, a leading European pharmaceutical company specialized in ophthalmology. We are committed to improving patients' quality of life through innovation, scientific excellence, and the highest standards of regulatory compliance.

We are looking for a Regulatory Affairs to join our Spanish affiliate on a fixed-term basis and provide regulatory support for approximately 8–11 months. This position offers a unique opportunity to gain exposure to a broad range of regulatory activities across pharmaceuticals, medical devices, cosmetics, food supplements, promotional review, and lifecycle management within an international environment.

Key Responsibilities

Reporting to the Technical Director and working closely with both local and Group Regulatory Affairs teams, the successful candidate will:

• Monitor and assess Spanish and European regulatory requirements applicable to pharmaceuticals, medical devices, cosmetics, food supplements, and pharmaceutical companies.
• Support the preparation of documentation required for marketing authorization applications, variations, renewals, responses to authorities, and other lifecycle management activities for medicinal products.
• Collaborate with Théa Group Regulatory Affairs teams to ensure timely submission and maintenance of registrations in line with corporate regulatory strategies.
• Assist in the preparation and submission of local regulatory filings related to medical devices, cosmetics, and food supplements to obtain and maintain marketing authorizations in Spain.
• Support the preparation and maintenance of health licenses, permits, and regulatory authorizations required for the company's activities in Spain.
• Review promotional and non-promotional materials in collaboration with Compliance, Medical Affairs, and Commercial teams, ensuring consistency with approved product information, marketing authorizations, applicable regulations, industry codes, and internal company policies.
• Support notifications and submissions to local authorities related to advertising and promotional activities when required.
• Participate in the approval workflow for packaging materials, artworks, labelling, and product information, ensuring alignment with approved dossiers and regulatory requirements.
• Maintain accurate regulatory documentation, records, databases, and archives in accordance with internal procedures and regulatory expectations.
• Participate in cross-functional and international meetings, ensuring alignment between local and Group objectives.

Candidate Profile

Required Qualifications

• University degree in Pharmacy, Life Sciences, Biology, Chemistry, Biochemistry, or a related scientific discipline.
• 2-3y. Previous experience in Regulatory Affairs within the pharmaceutical, medical device, healthcare, or related industry.
• Knowledge of Spanish and European regulatory requirements.
• Strong attention to detail and excellent documentation management skills.
• Ability to manage multiple priorities and work effectively in a matrix and international environment.
• Fluency in both Spanish and English (written and spoken).

Preferred Qualifications

• Experience within a pharmaceutical affiliate.
• Exposure to medicinal products, medical devices, cosmetics, and/or food supplements.
• Experience interacting with AEMPS or other health authorities.
• Experience reviewing promotional materials and working with Compliance and Medical Affairs teams.
• Familiarity with artwork, labelling, and packaging approval processes.

What We Offer

• Opportunity to join a leading international ophthalmology-focused pharmaceutical company.
• Broad exposure to multiple healthcare product categories and regulatory frameworks.
• Cross-functional collaboration with Regulatory Affairs, Medical Affairs, Compliance, Commercial, and international teams.
• Dynamic and collaborative working environment.
• Hybrid working model.
• Fixed-term contract for approximately 8–11 months.

If you are looking for an opportunity to further develop your regulatory expertise within a dynamic and international environment, we would be delighted to hear from you.

Join Théa Spain and help bring innovation in ophthalmology to patients.

Información extra

Status

Activa

Estudios requeridos

E.S.O

Localización

Barcelona

Tipo de contrato

Trabajo estudiantes

Publicado el

10-07-2026

Carnet de conducir

No

Vehículo

No

Carta de motivación

No

Idiomas

Español